Myofunctional Therapy for Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assess throat muscle function in individuals with obstructive sleep apnea (OSA) using high-resolution manometry. Participants will use myofunctional therapy devices, which strengthen the mouth and throat muscles, for three months. Researchers will measure muscle pressure during activities such as swallowing and breathing. The goal is to understand how this therapy might improve sleep. This trial suits adults with a new OSA diagnosis or those who haven't found success with other treatments and are willing to pause current OSA treatments for three months. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for OSA.
Will I have to stop taking my current medications?
The trial requires participants to stop their current OSA (obstructive sleep apnea) treatment for 3 months. It does not specify about other medications, so you may need to discuss this with the trial coordinators.
What prior data suggests that this technique is safe for examining muscle function?
Research has shown that myofunctional therapy (MFT) is generally safe and well-tolerated by people with obstructive sleep apnea (OSA). Studies have found that MFT can reduce the severity of sleep apnea by about 50% in adults, indicating its effectiveness and safety for many individuals. No major reports of serious side effects or harm have emerged from using MFT. The treatment primarily involves exercises to strengthen the muscles used for swallowing and breathing, which helps improve sleep. Overall, the evidence supports the safety of MFT for those considering participation in a clinical trial.12345
Why are researchers excited about this trial?
Most treatments for obstructive sleep apnea, like CPAP machines and oral appliances, focus on managing symptoms by keeping airways open during sleep. Myofunctional Therapy is unique because it targets the root cause by strengthening the muscles involved in breathing and swallowing. This approach is non-invasive and aims to improve muscle function through high-intensity swallowing exercises and respiratory muscle strength training. Researchers are excited because this method has the potential to offer a long-term solution by naturally enhancing airway stability without the continuous use of devices.
What evidence suggests that myofunctional therapy is effective for obstructive sleep apnea?
Research shows that myofunctional therapy (MFT) can greatly help people with obstructive sleep apnea (OSA). Studies have found that this therapy can reduce the severity of sleep apnea by about half in adults, leading to fewer breathing interruptions during sleep. MFT involves exercises to strengthen the muscles in the mouth and throat, helping to keep airways open. In this trial, participants will undergo MFT as the sole intervention. Overall, MFT offers a promising option for reducing the severity of OSA.13678
Who Is on the Research Team?
Jesse Hoffmeister, PhD, CCC-SLP
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
Adults with Obstructive Sleep Apnea (OSA) are eligible for this trial. Participants will use myofunctional therapy devices and undergo high-resolution manometry to measure throat muscle function during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use myofunctional therapy (MFT) devices for 3 months, including high-intensity swallowing exercises and respiratory muscle strength training
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Myofunctional Therapy
Trial Overview
The trial is testing myofunctional therapy (MFT), a technique that may improve sleep by strengthening throat muscles in OSA patients. The effectiveness of MFT is measured using high-resolution manometry before and after the intervention.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The intervention consists of 90 days of MFT (5-6 days/week) along with completing daily logs. MFT will include high-intensity swallowing exercises and respiratory muscle strength training. Before and after the MFT intervention period, there will be a research visit that includes answering questionnaires about symptoms and health, performing throat HRM, and assessing oral and facial muscles involved in swallowing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Myofunctional Therapy to Treat Obstructive Sleep Apnea
Current literature demonstrates that myofunctional therapy decreases apnea-hypopnea index by approximately 50% in adults and 62% in children.
Efficacy of myofunctional therapy for obstructive sleep apnea
This systematic review and network meta-analysis of randomized controlled trials (RCTs) aims to evaluate the efficacy of MT in treating adult and pediatric OSA.
NCT04608552 | Effect of Myofunctional Therapy on OSA
The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.
Myofunctional Therapy for the Treatment of Obstructive Sleep ...
The effectiveness of the OMT in the treatment of adult OSA patients was verified, both alone and in association with other interventions, through the reduction ...
Myofunctional Therapy in Adults and Children With ...
Overall, MT significantly reduced the severity of sleep apnea (MD AHI −8.95; 95% CI −11.80; −6.11; 12 studies; 277 participants; I2 77%) and ...
Myofunctional Therapy for Obstructive Sleep Apnea
Also called a data safety and monitoring board, or DSMB. Early Phase ... Myofunctional Therapy for Obstructive Sleep Apnea.
[Myofunctional therapy (oropha - HTA Database - inahta
CONCLUSIONS • Myofunctional therapy for OSA patients, compared to no intervention, waitlist, or placebo/sham, demonstrated benefits in outcomes such as sleep ...
Orofacial Myofunctional Therapy in Obstructive Sleep ...
Myofunctional therapy helps to reposition the tongue, improve nasal breathing, and increase muscle tone in pediatric and adult OSA patients.
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